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A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata
Led by Aldena Therapeutics · Updated on 2026-03-04
24
Participants Needed
7
Research Sites
88 weeks
Total Duration
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AI-Summary
What this Trial Is About
The goal of this first-in-human clinical trial is to learn if ALD-102 Solution is safe and well tolerated following injections in the scalp in subjects with alopecia areata. The study will also learn about the effect of ALD-102 on hair regrowth in treatment areas. The researchers will compare the effects of ALD-102 Solution (drug) to placebo (saline solution that contains no drug) or an untreated area. Study participants will have treatment areas selected on the scalp to receive ALD-102 Solution (drug), placebo (saline solution) or to remain untreated. Injections will occur once every 4 weeks for a treatment period of 8 weeks.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 55 years at informed consent
- Body mass index between 18.0 and 35.0 kg/m2 at screening
- Body weight of at least 50 kg at screening
- Clinically confirmed diagnosis of alopecia areata at screening
- Presence of alopecia areata scalp lesions suitable for required number of injections per cohort (20 or 40 injections)
- Treatment areas must have near-complete or complete absence of terminal hairs and be clinically similar
- Control areas must be located at least 6 cm from treatment areas, clinically similar, and meet size requirements per cohort
- Current episode of hair loss at treatment and control areas lasting more than 6 months but less than 5 years, with possible hair regrowth
- No active hair regrowth or hair loss and no significant regrowth or loss in last 6 months
- Willing to maintain the same hairstyle and color during the trial
- Female subjects of childbearing potential must use effective contraception as specified, with negative pregnancy tests at screening and Day 1
- Male subjects must use condoms and ensure female partners use effective contraception as specified
- Willing and able to provide signed informed consent
- Willing to comply with all study procedures and available for study duration
- Willing to receive 20 to 40 intradermal injections every 4 weeks
You will not qualify if you...
- Very severe alopecia areata with SALT score of 95 or higher
- Presence of other types of alopecia besides alopecia areata (except distinct androgenetic alopecia not affecting treatment areas)
- Diffuse type of alopecia areata (ophiasis or siapho patterns allowed)
- History or presence of hair transplants or scalp micropigmentation
- Female who is breastfeeding, pregnant, or planning pregnancy during the study
- Immune deficiency or immunocompromised status
- History of cancer or lymphoproliferative disease within 5 years (except certain skin or cervical cancers)
- Major surgery within 8 weeks prior or planned during study
- Significant medical conditions or abnormalities affecting safety or trial results
- Positive tests for hepatitis B, hepatitis C (unless cured), or HIV
- Recent serious infections or active infections requiring treatment
- Abnormal blood counts or liver/kidney function tests
- History of heart disease or currently on anticoagulants
- Active inflammatory skin diseases on scalp that interfere with evaluation
- Tattoos, open sores or skin damage in treatment/control areas
- Recent use of systemic inflammatory treatments or investigational products
- Use of live vaccines within 4 weeks prior or planned during study
- Use of systemic or intralesional steroids within 8 weeks prior
- Use of treatments affecting hair regrowth within 4 weeks prior
- Previous ineffective use of systemic JAK inhibitors for alopecia areata
- Recent platelet-rich plasma injections or biological agents
- History of certain biologic therapies within 12 months
- Use of exogenous androgens or anabolic steroids within 6 months
- Allergic reactions to ALD-102 or local anesthetics
- History of hypertrophic scarring or keloids
- Recent use of anticoagulant medications or contraindications to skin biopsies
- Inability to tolerate injections or needle sensitivity
- Institutionalized due to legal or regulatory order
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Clinical Trial Research Institute
Thousand Oaks, California, United States, 91320
Actively Recruiting
2
Options Research Group
West Lafayette, Indiana, United States, 47906
Actively Recruiting
3
The Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Dermatology Specialists of Spokane
Spokane, Washington, United States, 99202
Actively Recruiting
5
The Centre for Clinical Trials
Oakville, Ontario, Canada, L6J 7W5
Actively Recruiting
6
Innovaderm
Montreal, Quebec, Canada, H2X 2V1
Actively Recruiting
7
Centre de Recherche Saint-Louis
Québec, Quebec, Canada, QC G1W 4R4
Actively Recruiting
Research Team
C
Chief Scientific Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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